drugset / Trial / NCT02264873

Phase I, Dose Escalation Study of Decitabine

NCT02264873 ↗

NaSingle-groupOpen-labelTreatment

Summary

Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune system and lead to a longer disease free survival. The study is designed to provide safety data of low-dosing in the post-transplant setting.

Timeline

Start
2014-10
Primary completion
2016-10
Completion
2018-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 5 mg —
Subject Decitabine Small molecule 7.5 mg —
Subject Decitabine Small molecule 10 mg —
Subject Decitabine Small molecule 12.5 mg —